CytomX Therapeutics to Present at the 2019 Wedbush PacGrow Healthcare Conference

On August 6, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that it will present at the 2019 Wedbush PacGrow Healthcare Conference (Press release, CytomX Therapeutics, AUG 6, 2019, View Source [SID1234538203]). Sean McCarthy, D.Phil., president, chief executive officer and chairman, will present a corporate overview on August 13, 2019, at 10:20 a.m. ET.

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 30 days following the event.

Gamida Cell Reports Second Quarter 2019 Financial Results and Provides Company Update

On August 6, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported financial results for the quarter ended June 30, 2019 (Press release, Gamida Cell, AUG 6, 2019, View Source [SID1234538219]). The company also highlighted continued progress in advancing its clinical development candidates: omidubicel, an investigational advanced cell therapy in Phase 3 clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

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"During the past quarter, Gamida Cell made important progress toward its goal of transforming the treatment landscape for patients with blood cancers and rare, serious hematologic diseases," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are continuing to progress our multi-center, randomized Phase 3 study of omidubicel to enable a topline data readout, which is expected in the first half of 2020. As we look ahead toward the potential submission of a biologics license application next year, we are advancing key activities required to bring omidubicel to patients in a commercial setting. To help ensure that we will have sufficient and reliable commercial supply, we established a commercial manufacturing supply agreement with Lonza and engaged Biopharmax, a biopharmaceutical design and construction firm, to initiate the construction of our own commercial manufacturing facility in Israel."

"Our second cell therapy program, GDA-201, is also moving forward. We anticipate additional data from the ongoing Phase 1/2 clinical study in the second half of the year. We are also on track with our plans to develop a cryopreserved formulation of GDA-201 to enable a multi-center clinical study in patients with non-Hodgkin lymphoma," Dr. Adams continued. "Both omidubicel and GDA-201 are based on our proprietary cell expansion platform, which has the potential to further expand our pipeline. In June, we appointed Dr. Tracey Lodie to our team as chief scientific officer to set our scientific strategy and lead new translational research to further elucidate the potential of our technology and clinical development programs."

Program Highlights

Continued to advance the Phase 3 clinical study of omidubicel: Patient enrollment continued to progress in the Gamida Cell’s Phase 3 study of omidubicel in patients with high-risk hematologic malignancies. The international, randomized, multi-center study is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood for allogeneic bone marrow transplant in approximately 120 patients with no available matched donor. The company anticipates completing patient enrollment by the end of this year with topline data anticipated in first half of 2020.
Established agreements to support commercial manufacturing for omidubicel: In June, Gamida Cell and Lonza announced that the companies entered into a strategic manufacturing agreement for the future commercial production after potential FDA approval of omidubicel. This agreement follows a successful multi-year clinical manufacturing relationship and provides Gamida Cell with a path to commercial supply of omidubicel. Under this multi-year agreement, Lonza will construct and dedicate production suites at its Geleen, NL site for the anticipated commercial launch. Additionally, the agreement enables Gamida Cell to increase the number of dedicated production suites over time to ensure commercial supply. Gamida Cell also has the option of expanding further into Lonza’s global cell and gene therapy manufacturing network. In August, Gamida Cell signed an agreement with Biopharmax for the construction of suites for the commercial manufacture of omidubicel after potential FDA approval of omidubicel at a Gamida Cell-operated facility in Israel.
Initiated enrollment for Cohort 2 in the Phase 1/2 study of omidubicel in patients with severe aplastic anemia: In June, patient enrollment began in Cohort 2 of the investigator-sponsored, Phase 1/2 clinical study of omidubicel in patients with severe aplastic anemia, a rare and life-threatening blood disorder. Earlier this year, encouraging data from Cohort 1 were reported at the 2019 Transplantation & Cellular Therapy (TCT) Meeting. All three patients enrolled in Cohort 1 successfully underwent a bone marrow transplant consisting of omidubicel plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated immune recovery observed in these patients enabled the initiation of Cohort 2, where patients will be treated with omidubicel as a stand-alone graft.
Demonstrated continued progress with GDA-201 clinical development program: Gamida Cell continued to make progress with the GDA-201 clinical development program. The investigator-sponsored, Phase 1/2 clinical study of GDA-201 in patient with non-Hodgkin lymphoma and multiple myeloma is ongoing, with additional data expected in the second half of 2019. The company is developing a cryopreserved formulation of GDA-201 to enable a multi-center, multi-dose Phase 1/2 clinical study in patients with non-Hodgkin lymphoma, which is expected to begin next year.
Corporate Highlights

Completed public follow-on offering of approximately $40 million in gross proceeds: In July, Gamida Cell announced that the company closed an underwritten public offering of 7,000,000 ordinary shares and that the underwriters exercised in full their option to purchase an additional 1,050,000 ordinary shares at the public offering price of $5.00 per share. The aggregate gross proceeds to Gamida Cell from the offering, including the shares sold pursuant to the underwriters’ option, before deducting underwriting discounts and commission and offering expenses, were $40.3 million.
Bolstered management team with appointment of Tracey Lodie, Ph.D., as chief scientific officer: In June, the company announced the appointment of Tracey Lodie, Ph.D., as chief scientific officer. Prior to joining Gamida Cell, Dr. Lodie served as senior vice president, translational immunology at BlueRock Therapeutics, where she helped to advance their universal pluripotent stem cell platform into central nervous system, cardiovascular, and autoimmune therapeutic areas. She also served as vice president of immunology at Syros Pharmaceuticals, where she developed new autoimmunity and immuno-oncology research programs. Prior to Syros Pharmaceuticals, Dr. Lodie spent over 14 years at Sanofi-Genzyme, where she held roles of increasing responsibility. She obtained a PhD. in immunology and pathology at Boston University School of Medicine before completing a post-doctoral fellowship at Beth Israel Deaconess Medical Center in the Department of Hematology/Oncology.
Shawn Cline Tomasello and Stephen Wills elected to Board of Directors, reflecting company’s progress toward commercialization: In June, Shawn Cline Tomasello and Stephen T. Wills were elected to Gamida Cell’s board of directors. Ms. Tomasello has extensive experience in commercializing first-in-class medicines for the treatment of cancer, including Yescarta (at Kite Pharma, now part of Gilead Sciences) and Imbruvica (at Pharmacyclics, now part of AbbVie). Mr. Wills has extensive operational, financial and transactional experience over nearly three decades in the life sciences and accounting industries. He has served as chief financial officer of Palatin Technologies, a publicly-traded biotechnology company developing peptide therapeutics, since 1997 and also serves as Palatin’s chief operating officer and executive vice president.
Anticipated 2019-2020 Milestones

Gamida Cell’s anticipated program milestones in 2019-2020 are as follows:

Omidubicel

Complete enrollment in Phase 3 study of omidubicel in patients with hematologic malignancies by the end of 2019
Report topline data from the Phase 3 study of omidubicel in patients with hematologic malignancies in the first half of 2020
Complete BLA submission for omidubicel in hematologic malignancies in the second half of 2020, should Phase 3 data be positive
GDA-201

Complete patient enrollment in the ongoing Phase 1 study in the second half of 2019
Present additional data at a medical meeting in the second half of 2019
Initiate multi-center, Phase 1/2 clinical study in patients with NHL in 2020
Second Quarter 2019 Financial Results

Research and development (R&D) expenses in the second quarter of 2019 were $7.0 million and were also $7.0 million in the same period in 2018. R&D expenses were higher in the second quarter of 2019 compared to the same period in 2018 due to the advancement of omidubicel and GDA-201 but were offset by a $2.0 million increase in grants related to the Israeli Innovation Authority (IIA).
General and administrative expenses were $3.8 million for the second quarter of 2019, compared to $2.9 million in the same period in 2018. The difference was attributable mainly to a $0.4 million increase in cash and non-cash expenses related to hiring and establishing the U.S. headquarters as well as a $0.5 million increase in professional services, including an increase in expenses associated with being a publicly-traded company.
Finance income, net, was $16.8 million for the second quarter of 2019, compared to finance expenses, net, of $3.2 million in the same period in 2018. The net increase was primarily due to non-cash income resulting from the re-valuation of warrants, offset by non-cash expenses from the re-valuation of the IIA royalty-bearing grant liability.
Net income for the second quarter of 2019 was $6.0 million, compared to a net loss of $13.1 million in the same period in 2018.
As of June 30, 2019, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $41.7 million, compared to $60.7 million as of December 31, 2018. The June 30, 2019, cash position excludes the aggregate gross proceeds from the company’s recent public follow-on offering, which were $40.3 million.

2019 Financial Guidance
Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35 million to $40 million, reflecting anticipated expenditures to advance the company’s clinical programs.

Gamida Cell expects that its cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the fourth quarter of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Conference Call Information
Gamida Cell will host a conference call today, August 6, 2019, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 2127937. A replay of the webcast will be available for approximately 30 days.

About Omidubicel
Omidubicel (formerly known as NiCord), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.1 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.4

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

United Therapeutics Corporation To Present At 2019 Wedbush PacGrow Healthcare Conference

On August 6, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported that Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics, will provide an overview and update on the company’s business at the 2019 Wedbush PacGrow Healthcare Conference in New York City (Press release, United Therapeutics, AUG 6, 2019, View Source [SID1234538235]).

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The presentation will take place on Tuesday, August 13, 2019, at 10:20 AM Eastern Time, and can be accessed via a live webcast on the United Therapeutics website at View Source under the "Investors" tab in the "Events and Presentations" section. An archived, recorded version of the presentation will be available approximately twenty-four hours after the presentation ends and can be accessed at the same location for 90 days. [uthr-g]

Harpoon Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 5, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the second quarter and six months ended June 30, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 5, 2019, View Source [SID1234538132]).

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"I am pleased with the exciting progress Harpoon has made so far in 2019 with two T cell engagers, HPN424 and HPN536, in the clinic as planned," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "The dose escalation portion of the clinical trial for our lead product candidate, HPN424, continues to advance and we expect to present an interim dataset during the first half of 2020 at an appropriate medical meeting. Our confidence in our TriTAC platform continues to solidify as we learn more about its capabilities and promise."

"Consistent with the TriTAC mechanism of action, we observed T cell activation and cytokine induction with HPN424 treatment, which prompted us to explore the use of dexamethasone as a premedication to limit potential adverse events," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics. "We have found that the addition of weekly dexamethasone premedication, tapered over several weeks, has successfully limited adverse events. When patients completed the scheduled taper, they continued to receive weekly HPN424, without dexamethasone, with no complications observed thus far. This strategy has allowed us to proceed with dose escalations of HPN424 and further advance this promising potential therapy."

Second Quarter 2019 Business Highlights and Other Recent Developments

HPN424, Harpoon’s lead product candidate in development as a potential treatment for prostate cancer, continues to enroll patients in a Phase 1 clinical trial. The treatment regimen has been modified to include premedication with dexamethasone, tapered over several weeks. Several patients have completed the scheduled taper, and have successfully continued treatment with HPN424 in the absence of dexamethasone. Enrollment is ongoing, with patients now being treated in the seventh dose-escalation cohort. Pharmacokinetics observed to date continue to support once-weekly dosing of HPN424. Harpoon plans to present interim results at a medical meeting in the first half of 2020.

In April, Harpoon advanced its second TriTAC, HPN536, a mesothelin-targeting T cell engager, into the clinic and dosed the first patient in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. Patient enrollment continues as planned and two dosing cohorts have been completed. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients, followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is collecting data to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.

Anticipated Milestones

HPN424 – present interim Phase 1 data in the first half of 2020 at a medical conference and initiate expansion cohort in 2020

HPN536 – present proof of concept data in 2020

HPN217 – submit IND by the end of 2019 and initiate Phase 1 trial in the first quarter of 2020

HPN328 – initiate Phase 1 trial in 2020

Second Quarter Financial Results

Harpoon Therapeutics ended the second quarter of 2019 with $133.9 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $71 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the second quarter ended June 30, 2019 was $11.8 million compared to $6.0 million for the second quarter ended June 30, 2018. The net loss for the six months ended June 30, 2019 was $25.4 million compared to $10.9 million in the first six months of the prior year.

Revenue for the second quarter of 2019 was $1.1 million compared to $1.1 million for the second quarter of 2018. For the six months ended June 30, 2019, revenue was $2.1 million compared to $2.6 million for the six months ended June 30, 2018. For the six months ended June 30, 2019, the decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc. During both the three and six month periods, revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under the collaboration agreement with AbbVie.

Research and development (R&D) expense for the second quarter of 2019 was $10.0 million compared to $6.2 million for the second quarter of 2018. For the six months ended June 30, 2019, R&D expense was $19.4 million, compared to $11.7 million for the six months ended June 30, 2018. The increase for both periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative (G&A) expense for the second quarter of 2019 was $3.7 million compared to $1.0 million for the second quarter of 2018. G&A expense for the six months ended June 30, 2019 was $9.6 million compared to $1.9 million for the six months ended June 30, 2018. The increase for both periods was due to an increase in consulting and accounting services primarily related to the 2018 audit, legal fees, headcount, and other professional services to support our ongoing operations as a public company.

China Biologic Reports Financial Results for the Second Quarter of 2019

On August 5, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the second quarter of 2019 (Press release, China Biologic Products, AUG 5, 2019, View Source [SID1234538148]).

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Second Quarter 2019 Financial Highlights

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms and 12.7% in USD terms to $135.7 million from $120.4 million in the same quarter of 2018.
Gross profit increased by 9.9% to $90.9 million from $82.7 million in the same quarter of 2018. Gross margin decreased to 67.0% from 68.7% in the same quarter of 2018.
Income from operations increased by 34.3% to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% from 29.8% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 23.1% in RMB terms and 15.2% in USD terms to $56.7 million from $49.2 million in the same quarter of 2018.
Net income attributable to the Company increased by 55.2% in RMB terms and 45.5% in USD terms, to $41.6 million from $28.6 million in the same quarter of 2018. Fully diluted earnings per share increased to $1.06 compared to $0.83 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms to $48.7 million from $40.2 million in the same quarter of 2018. Non-GAAP adjusted earnings per share increased to $1.24 from $1.17 in the same quarter of 2018.
"China Biologic continued to deliver solid financial results in the second quarter, driven primarily by higher-than-usual sales volumes of albumin and a high growth in sales volume for certain hyper-immunoglobulin products. However, IVIG sales remained sluggish, and the growth of albumin sales slowed down. While we closely monitor the impact of changes in the policy and market environment, we maintain our outlook for the year," said Joseph Chow, Chairman and CEO of China Biologic.

"As expected, the growth in albumin sales that we had experienced in the first quarter decelerated during the second quarter, reflecting the alleviation of the albumin supply shortage situation in the market due to relaxation of import constraints imposed in the earlier months of 2019. We expect growth in albumin sales to slow down further during the second half of the year, as a result of our relatively fixed level of annual production of albumin and the large volume of albumin which was oversold in the first half of the year. Sales of IVIG products during the second quarter still lagged behind our expectations, reflecting the continued negative impact of the policy controls on higher-unit-cost prescription drugs. Looking ahead, our polypeptide products may be included in China’s national and regional key drug lists for monitoring and prescription control, which we expect would significantly impact its sales. In addition, due to the increase of our account receivable turnover days relative to peer companies in the last two quarters, we have decided to begin a comprehensive review of our existing credit sale policies regarding pricing and credit terms, and to increase collection efforts to ensure our credit exposure is within the limits of our risk tolerance level. These measures could potentially impact our sales in the near term."

"In June, we obtained approval from the China National Medical Products Administration to begin human clinical trials on a Human von Willebrand Factor (VWF) product, which is intended to be used for the treatment of bleeding episodes including surgical bleeding in patients with von Willebrand disease. We expect that it will take approximately three years to complete the clinical trials. In late July, we received the operating permit for our new Wenchang plasma collection station in Hainan Province and immediately commenced commercial operations. We are also pleased to announce that in early August we completed the acquisition of the remaining 20% interest in TianXinFu and made it an indirect wholly-owned subsidiary of the Company, which will allow us to fully capture the growth potential of this leading player in the regenerative medical bio-material industry, better realize the synergies between TianXinFu’s business and China Biologic’s high-end coagulation factor business, and receive the full benefits and earnings accretion from existing and future TianXinFu products."

"Moving forward, with a stable and experienced team in place, we will continue our efforts to execute our sales and marketing strategies, including expanding our sales coverage and enhancing promotion of IVIG and high-end coagulation factor products to improve their prescription volumes in hospitals."

Appointment of Joseph Chow as CEO

The Company reported that its board of directors (the "Board") has appointed Mr. Joseph Chow as the CEO of the Company, effective August 5, 2019.

Mr. Chow is an experienced executive and has held managerial positions in various public and private companies. Mr. Chow has been a member of our Board since November 2014, our Chairman since February 2019 and our acting CEO since May 2019. After the departure of our former CEO in May 2019, the Board formed a search committee to seek a new CEO for the Company. After several months’ search and evaluation of both internal and external candidates, the search committee recommended Mr. Chow to the Board and the Board approved his appointment. The Board believes that, with his deep understanding of the Company and extensive experience in corporate finance and management, Mr. Chow is well qualified for the position and will lead the Company towards long-term sustainable growth.

Mr. Chow will continue to serve as a director and the Chairman of the Company. In order to fully devote to the affairs of the Company, Mr. Chow has resigned from all positions he previously held at Centurium Capital and no longer holds any interest in Centurium Capital or funds managed by it.

Mr. Chow stated, "I am thankful for the confidence and trust the Board has placed in me as the Company’s new CEO. I am looking forward to working with the management, employees and partners to redevelop the future roadmap for our business that charts its course and ensures long-term improved and sustainable growth."

Share Repurchase Program

In May 2019, the Board authorized a share repurchase program under which China Biologic may repurchase up to US$150 million worth of shares over a 12-month period. As of June 30, 2019, the Company had repurchased 121,852 shares at a total of $11.0 million under this program.

Second Quarter 2019 Financial Performance

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms, or 12.7% in USD terms, to $135.7 million from $120.4 million in the same quarter of 2018.

Total sales for biopharmaceutical products (including plasma products and placenta polypeptide products) increased by 21.6% in RMB terms, or 14.0% in USD terms, to $122.3 million from $107.3 million in the same quarter of 2018, as a result of increased sales of human albumin products, certain hyper-immune products and coagulation factor products, which was partly offset by decreased sales of placenta polypeptide products. For plasma products, total sales in the second quarter of 2019 increased by 31.2% in RMB terms, or 22.8% in USD terms, to $111.0 million from $90.3 million in the same quarter of 2018.

Total sales for biomaterial products in the second quarter of 2019 increased by 9.9% in RMB terms, or 3.1% in USD terms, to $13.4 million from $13.0 million in the same quarter of 2018, as a result of higher sales concentration of higher-unit-price artificial dura mater products.

During the second quarter of 2019, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 36.9% in RMB terms, or 28.3% in USD terms, from $38.1 million in the second quarter of 2018 to $48.9 million in the second quarter of 2019. Revenue from IVIG products increased by 4.0% in RMB terms, or decreased by 2.5% in USD terms, from $28.1 million in the second quarter of 2018 to $27.4 million in the second quarter of 2019. As a percentage of total sales, sales from human albumin and IVIG products were 36.0% and 20.2%, respectively, in the second quarter of 2019.

Sales volume of human albumin products increased by 38.2% for the second quarter of 2019, primarily due to increased sales volumes in the distributor and pharmacy channels, supplemented by increased direct sales to hospitals and inoculation centers. The sales volume of IVIG products increased by 5.3% for the second quarter of 2019 as a result of increased sales through the direct sales channel.

The average prices for human albumin and IVIG products decreased by 0.9% and 1.2%, respectively, in RMB terms in the second quarter of 2019 compared to the same quarter of 2018 because of higher sales volume in the distributor channel and lower prices to certain distributors reflecting intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products decreased by 7.2% and 7.5%, respectively, in the second quarter of 2019 compared to the same quarter of 2018.

Revenue from other immunoglobulin products increased by 31.9% in RMB terms, or 23.5% in USD terms in the second quarter of 2019 compared to the same quarter of 2018, reaching 14.0% of total sales as compared to 12.8% of total sales in the same quarter of 2018. The revenue increase was mainly attributable to increased sales volume of human rabies immunoglobulin and human tetanus immunoglobulin products.

Revenue from other plasma products, including human coagulation factor VIII, human prothrombin complex concentrate, and human fibrinogen products, increased by 92.7% in RMB terms, or 80.5% in USD terms, in the second quarter of 2019 compared to the same quarter of 2018, representing 11.5% of total sales in the second quarter of 2019. The growth mainly came from increased sales through the distributor channel.

Revenue from placenta polypeptide products decreased by 29.0% in RMB terms, or 33.5% in USD terms for the second quarter of 2019 as compared to the same quarter of 2018, accounting for 8.3% of total sales compared to 14.1% of total sales in the second quarter of 2018, mainly in line with a decrease in sales volume as a result of the inclusion of placenta polypeptide products in regional adjuvant drug lists, which put a downward pressure on their prescription volume.

Cost of sales increased by 19.1% to $44.8 million in the second quarter of 2019 from $37.6 million in the same quarter of 2018. As a percentage of total sales, cost of sales increased to 33.0% from 31.2% in the same quarter of 2018, mainly due to decreased sales prices for most of the Company’s plasma products and increased plasma collection costs.

Gross profit increased by 9.9% to $90.9 million in the second quarter of 2019 from $82.7 million in the same quarter of 2018. Gross margin was 67.0% and 68.7% in the second quarter of 2019 and 2018, respectively.

Total operating expenses in the second quarter of 2019 decreased by $4.2 million, or 9.0%, to $42.7 million from $46.9 million in the same quarter of 2018. This decrease mainly consisted of a decrease of $5.9 million in general and administrative expenses, partially offset by an increase of $1.2 million in selling expenses and $0.5 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.5% in the second quarter of 2019 from 39.0% in the same quarter of 2018.

Selling expenses in the second quarter of 2019 increased by $1.2 million, or 4.9%, to $25.6 million from $24.4 million for the second quarter of 2018. The increase is primarily due to increased selling expenses for plasma products and biomaterial products, which is partly offset by a decrease in marketing and promotion expenses related to placenta polypeptide products. As a percentage of total sales, selling expenses decreased to 18.9% for the second quarter of 2019 from 20.3% in the same quarter of 2018.

General and administrative expenses in the second quarter of 2019 decreased by $5.9 million, or 28.6%, to $14.7 million from $20.6 million in the same quarter of 2018. As a percentage of total sales, general and administrative expenses decreased to 10.8% for the second quarter of 2019 from 17.1% for the same quarter of 2018. The decrease in general and administrative expenses was mainly because of a decrease in share-based compensation expenses and a reversal of allowance for doubtful accounts receivable.

Research and development expenses in the second quarter of 2019 increased by $0.5 million, or 26.3%, to $2.4 million from $1.9 million in the same quarter of 2018. As a percentage of total sales, research and development expenses increased to 1.8% from 1.6% in the same quarter of 2018.

Income from operations in the second quarter of 2019 increased by 43.4% in RMB terms, or 34.3% in USD terms, to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% in the second quarter of 2019 from 29.8% in the second quarter of 2018.

Income tax expense in the second quarter of 2019 increased by 22.4%, to $8.2 million from $6.7 million in the same period of 2018. The effective income tax rate was 14.4% and 16.5% for the second quarter of 2019 and 2018, respectively.

Net income attributable to the Company increased by 55.2% in RMB terms, or 45.5% in USD terms, to $41.6 million in the second quarter of 2019 from $28.6 million in the same period of 2018. Net margin increased to 30.7% in the second quarter of 2019 from 23.8% in the same period of 2018. Diluted net earnings per share increased to $1.06 in the second quarter of 2019 compared to $0.83 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 23.1% in RMB terms, or 15.2% in USD terms, to $56.7 million in the second quarter of 2019 from $49.2 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms, to $48.7 million in the second quarter of 2019 from $40.2 million in the same period of 2018. Non-GAAP net margin increased to 35.9% in the second quarter of 2019 from 33.4% in the same period of 2018. Non-GAAP adjusted net income per diluted share increased to $1.24 in the second quarter of 2019 from $1.17 in the same period of 2018.

Non-GAAP adjusted income from operations for the second quarter of 2019 excludes $6.5 million in non-cash employee share-based compensation expenses, and $2.0 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the second quarter of 2019 exclude $5.6 million in non-cash employee share-based compensation expenses, and $1.4 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

First Half 2019 Financial Performance

Total sales in the first half of 2019 increased by 21.3% in RMB terms, or 14.0% in USD terms, to $265.5 million from $232.8 million in the same period of 2018.

Total sales for biopharmaceutical products increased by 21.9% in RMB terms, or 14.5% in USD terms, to $238.7 million from $208.4 million in the same period of 2018, as a result of increases in the sales of human albumin products, immunoglobulin products and coagulation factor products, which was partly offset by decreases in the sales of placenta polypeptide products. For plasma products, total sales in the first half of 2019 increased by 33.4% in RMB terms, or 25.4% in USD terms, to $219.8 million from $175.3 million in the same period of 2018. As a percentage of total sales, sales from human albumin and IVIG products accounted for 39.8% and 21.3%, respectively, in the first half of 2019.

Total sales for biomaterial products in the first half of 2019 increased by 16.4% in RMB terms, or 9.4% in USD terms, to $26.7 million from $24.4 million in the same period of 2018, as a result of higher sales concentration in higher-unit-price artificial dura mater products.

Cost of sales increased by 24.8% to $89.0 million in the first half of 2019 from $71.3 million in the same period of 2018. As a percentage of total sales, cost of sales increased to 33.5% from 30.6% in the same period of 2018, mainly because of decreased sales prices for most of the Company’s plasma products, and increased plasma collection costs.

Gross profit increased by 9.3% to $176.5 million in the first half of 2019 from $161.5 million in the same period of 2018. Gross margin was 66.5% and 69.4% in the first half of 2019 and 2018, respectively.

Total operating expenses in the first half of 2019 decreased by $2.3 million, or 2.7%, to $84.4 million from $86.7 million in the same period of 2018. This decrease mainly consisted of a decrease of $2.7 million in general and administrative expenses and $0.6 million in selling expense, partially offset by an increase of $1.1 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.8% in the first half of 2019 from 37.2% in the same period of 2018.

Income from operations in the first half of 2019 increased by 30.9% in RMB terms, or 23.1% in USD terms, to $92.1 million from $74.8 million in the same period of 2018. Operating margin increased to 34.7% in the first half of 2019 from 32.1% in the first half of 2018.

Income tax expense in the first half of 2019 increased by $2.6 million, or 19.3%, to $16.1 million from $13.5 million in the same period of 2018. The effective income tax rate was 14.7% and 15.9% for the first half of 2019 and 2018, respectively.

Net income attributable to the Company increased by 40.2% in RMB terms, or 31.7% in USD terms, to $79.3 million in the first half of 2019 from $60.2 million in the same period of 2018. Net margin increased to 29.9% in the first half of 2019 from 25.9% in the same period of 2018. Diluted net earnings per share increased to $2.01 in the first half of 2019 compared to $1.75 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 16.7% in RMB terms and 9.7% in USD terms to $108.9 million in the first half of 2019 from $99.3 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 21.6% in RMB terms, and 14.3% in USD terms, to $93.2 million in the first half of 2019 from $81.6 million in the same period of 2018. Non-GAAP net margin remained comparatively stable at 35.1% in the first half of 2019 compared with 35.0% in the same period of 2018. Non-GAAP adjusted net income per diluted share was $2.36 and $2.37, respectively, in the first half of 2019 and 2018.

Non-GAAP adjusted income from operations for the first half of 2019 excludes $12.8 million in non-cash employee share-based compensation expenses, and $4.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first half of 2019 exclude $11.1 million in non-cash employee share-based compensation expenses, and $2.8 million in amortization of intangible assets and land use rights related to the acquisition of TianXinFu.

As of June 30, 2019, the Company had $202.5 million in cash on hand and demand deposits, $523.9 million in time deposits, and $191.1 million in short term investments.

Net cash provided by operating activities for the first half of 2019 was $94.2 million as compared to $45.5 million for the same period of 2018. The $48.7 million increase in net cash provided by operating activities was a combined result of the increase in net income and a slowdown of increase in accounts receivable and inventories compared to the first half of 2018.

Accounts receivable increased by $15.2 million during the first half of 2019 as compared to $30.3 million during the same period of 2018. The accounts receivable turnover days for plasma products increased to 102 days during the first half of 2019 from 88 days during the same period of 2018, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distributor channel.

Inventories increased by $4.3 million in the first half of 2019, which was milder than the increase of $21.4 million in the same period of 2018. This reflected a lower level of albumin inventory attributable to higher-than-expected albumin sales, which was partially offset by higher IVIG inventory due to sluggish IVIG sales.

Net cash used in investing activities for the first half of 2019 was $117.5 million as compared to $168.9 million for the same period of 2018. During the first half of 2019, the Company paid $15.1 million for the acquisition of property, plant and equipment, intangible assets and land use rights, and the Company also purchased time deposits and short-term investments in the amount of $1,265.0 million. This was partly offset by $1,162.7 million from the maturity of time deposits and short term investments. Net cash used in investing activities in the first half of 2018 mainly consisted of $529.6 million payment for purchase of time deposits and short term investments, and $19.1 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $282.1 million time deposits and short term investments.

Net cash used in financing activities for the first half of 2019 was $114.9 million as compared to net cash provided by financing activities of $0.8 million for the same period of 2018. In the first half of 2019, $110.0 million was remitted to an investment bank by the Company to execute the previously approved share repurchase program on behalf of the Company. During this period, 1,196,228 shares were repurchased at a total amount of $111.0 million. Net cash provided by financing activities in the first half of 2018 represented proceeds of $0.8 million from stock options exercised.

Financial Outlook

The Company reiterates its forecast for the full year 2019. The company expects both non-GAAP adjusted income from operations and non-GAAP adjusted net income to increase by 4% to 6% in RMB terms over full year 2018 financial results.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on Tuesday, August 6, 2019, which is 7:30 pm Beijing Time on August 6, 2019, to discuss its second quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through August 13, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10133955

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source